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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05367414
Other study ID # Amine TERZI
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 13, 2020
Est. completion date June 23, 2021

Study information

Verified date May 2022
Source Artvin Coruh University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to determine the effect of aromatherapy massage on itching, comfort, skin pH level and skin moisture in individuals with liver disease. Research Hypotheses: H1: Aromatherapy massage has an effect on the level of itching in individuals with itchy liver disease. H2: Aromatherapy massage has an effect on the general comfort level in individuals with itchy liver disease, H3: Aromatherapy massage has an effect on skin pH level in individuals with itchy liver disease. H4: Aromatherapy massage has an effect on skin moisture in individuals with itchy liver disease.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date June 23, 2021
Est. primary completion date May 3, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - patients who volunteered to participate in the study, - with a diagnosis of chronic liver disease (liver cirrhosis (primary biliary cirrhosis, alcoholic, cardiac, post-necrotic, cryptogenic cirrhosis, Wilson's Cirrhosis, hemochromatosis), chronic viral hepatitis), - had no cognitive impairment, - were not included in the pre-application, - could answer questions, - itch score of above 3 (with Visual Analogue Scale). Exclusion Criteria: - patients are taking antipruritic treatment, - have itchy skin disease before, ulcer, eczema, etc. in the area to be applied - patients with dermatological problems, any swelling or signs of inflammation in the area ---to be treated, neuropathy or loss of sensation in the area to be treated - patients with allergic to tea tree oil, perfume, or cosmetics, - diagnosed with cancer

Study Design


Related Conditions & MeSH terms


Intervention

Other:
aromatherapy massage (diluted tea tree oil)
massage with diluted tea tree oil was applied
aromatherapy massage (sweet almond oil)
massage with sweet almond oil was applied

Locations

Country Name City State
Turkey Artvin Coruh University Artvin

Sponsors (1)

Lead Sponsor Collaborator
Amine Terzi

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Itching Itching was assessed with the 5D Itch Scale. The total score of the scale ranges from 5 to 25, with 5 points indicating the absence of itching and 25 points indicating the highest severity of itching. Day 1
Primary Itching Itching was assessed with the 5D Itch Scale. The total score of the scale ranges from 5 to 25, with 5 points indicating the absence of itching and 25 points indicating the highest severity of itching. Day 14
Primary comfort Comfort assessed with the General Comfort Scale. The score to be obtained from the scale varies between 48 and 192. 48 points indicating the low comfort level and 192 points indicating the high comfort level. Day 1
Primary comfort Comfort assessed with the General Comfort Scale.The score to be obtained from the scale varies between 48 and 192. 48 points indicating the low comfort level and 192 points indicating the high comfort level. Day 2
Primary comfort Comfort assessed with the General Comfort Scale. The score to be obtained from the scale varies between 48 and 192. 48 points indicating the low comfort level and 192 points indicating the high comfort level. Day 14
Primary skin pH level For pH level measurement, the F-74 G model skin pH measuring device manufactured by HORIBA Scientific and ISFET (Ion Sensitive Field Effect Transistor) 0040-10D model pH electrode produced by HORIBA Scientific were used. Day 1
Primary skin pH level For pH level measurement, the F-74 G model skin pH measuring device manufactured by HORIBA Scientific and ISFET (Ion Sensitive Field Effect Transistor) 0040-10D model pH electrode produced by HORIBA Scientific were used. Day 2
Primary skin pH level For pH level measurement, the F-74 G model skin pH measuring device manufactured by HORIBA Scientific and ISFET (Ion Sensitive Field Effect Transistor) 0040-10D model pH electrode produced by HORIBA Scientific were used. Day 14
Primary skin moisture level DMM brand skin moisture measuring device was used to measure skin moisture level. Day 1
Primary skin moisture level DMM brand skin moisture measuring device was used to measure skin moisture level. Day 2
Primary skin moisture level DMM brand skin moisture measuring device was used to measure skin moisture level. Day 14
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